The U.S. Centers for Disease Control and Prevention (CDC) has a high failure rate for the first batch of COVID-19 tests,media reported. As many as a third of the tests may have failed, according to the agency’s internal leaked findings. The revelations come as the U.S. added more than 106,000 new confirmed cases in a single day, and the total number of deaths now exceeds 233,000.
Although test kits are available internationally, the CDC is still working to develop its own version early in the outbreak. However, this did not go exactly as planned. Public testing agencies not only waited for the CDC kits, but when they finally arrived in early February, a problem soon a problem aded. After verification, the reagents in the kit did not play their due role at all. The chemical reagents did not validate the samples tested, but provided uncertain results.
The CDC was forced to return to the lab and redetrod the COVID-19 test kit. During that time, however, the number of new crown cases in the country has soared. Now, in the CDC’s internal review seen by NPR, exactly what went wrong — and how many defects there were in those initial diagnostic tests — has been revealed.
These diagnostic methods were developed in accordance with specific protocols created by the U.S. Food and Drug Administration (FDA), but the respiratory disease laboratory responsible for these kits did not stick to them. “No or no document control was performed to ensure that the use of a single verification of the correct test quality control procedures that matched the (emergency use authorization) procedure resulted in defects,” the review stressed.
In fact, according to the report, proper EMA validation was completed only at the end — when the kit was actually packed and ready to be shipped to the test site. They show that the system is very backward. “The first round (quality control) released by the final kit used an ‘incorrect’ test procedure,” the report said. “Late in the timeline, 33% of kit failures were detected” and the correct quality control protocol was used “without causing kit recalls or performance alerts”.
However, instead of dlosing, cdc labs continued to distribute. It was only when the first third-party validation tests began to go wrong that the agency acknowledged a problem with its kit.
The FDA insisted at the end of March 2020 that it was not responsible for detecting bottlenecks. Meanwhile, the U.S. Department of Health and Human Services (HHS) is investigating the failure of the first tests. It was not immediately clear when it would be announced.
Looking ahead, the CDC will ensure that new measures are in place to ensure that COVID-19 tests like this do not occur again. This includes new standards, test suites will be judged, etc. to ensure that they can be deployed to any public lab.